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RSS FeedPosted by Michael Wonder on 15 May 2026
Alloplex Biotherapeutics receives FDA fast track designation for Suplexa in colorectal cancer indication
13 May 2026 - Alloplex Biotherapeutics announces that the US FDA has granted fast track designation to Suplexa for the treatment ...
Posted by Michael Wonder on 15 May 2026
INmune Bio receives FDA fast track designation for XPro1595 in early Alzheimer's disease
14 May 2025 - INmune Bio today announced that the US FDA has granted fast track designation to XPro (pegipanermin), the ...
Posted by Michael Wonder on 12 May 2026
Coya Therapeutics has been granted US FDA fast track designation for COYA 302 for the treatment of amyotrophic lateral sclerosis
12 May 2026 - Coya Therapeutics today announced that the US FDA has granted fast track designation for COYA 302, ...
Posted by Michael Wonder on 12 May 2026
Sironax’s SARM1 inhibitor SIR2501 granted FDA fast track designation in chemotherapy-induced peripheral neuropathy
11 May 2026 - Sironax today announced that the US FDA has designated its SARM1 inhibitor SIR2501 as a fast track ...
Posted by Michael Wonder on 11 May 2026
Zai Lab receives US FDA fast track designation for zocilurtatug pelitecan (Zoci), a DLL3 targeting ADC, for treatment of extrapulmonary neuroendocrine carcinomas
11 May 2026 - Zai Lab today announced the US FDA has granted fast track designation to zocilurtatug pelitecan (zoci, formerly ...
Posted by Michael Wonder on 07 May 2026
Repertoire Immune Medicines announces FDA fast track designation for its investigational immune medicine, RPTR-1-201
7 May 2026 - Repertoire Immune Medicines today announced that the US FDA has granted fast track designation to RPTR-1-201 for ...
Posted by Michael Wonder on 07 May 2026
Armata Pharmaceuticals secures FDA fast track designation for AP-SA02
7 May 2026 - Armata Pharmaceuticals today announced that the US FDA has granted fast track designation to AP-SA02, the Company's ...
Posted by Michael Wonder on 07 May 2026
Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma
6 May 2026 - Diakonos Oncology announced today that the US FDA has granted fast track designation to DOC1021, the ...
Posted by Michael Wonder on 05 May 2026
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from fentanyl
5 May 2026 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 05 May 2026
Spinogenix receives US FDA fast track designation for tazbentetol for the treatment of ALS
5 May 2026 - Spinogenix today announced that the US FDA has granted fast track designation to tazbentetol for the ...
Posted by Michael Wonder on 01 May 2026
MRM Health’s lead candidate MH002 granted fast track designation by US FDA for the treatment of mild to moderate ulcerative colitis
30 April 2026 - MRM Health today announced that MH002, the Company’s lead rationally designed live biotherapeutic product candidate, has been ...
Posted by Michael Wonder on 30 Apr 2026
Expression Therapeutics receives FDA fast track and rare paediatric disease designations for investigational stem cell therapy for haemophilia A
29 April 2026 - Expression Therapeutics today announced that the US FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 28 Apr 2026
Scancell receives FDA fast track designation for iSCIB1+ in advanced melanoma
28 April 2026 - Scancell Holdings announces that the US FDA has granted fast track designation for its lead ImmunoBody iSCIB1+ ...
Posted by Michael Wonder on 28 Apr 2026
Prothena announces Novo Nordisk obtains fast track designation from the US FDA for coramitug (PRX004) in ATTR amyloidosis with cardiomyopathy
27 April 2026 - Prothena today announced that the US FDA has granted fast track designation to coramitug, a potential best ...
Posted by Michael Wonder on 23 Apr 2026
Debiopharm announces FDA fast track designation for lunresertib in combination with zedoresertib for genomic defined platinum-resistant ovarian cancer
23 April 2026 - Debiopharm today announced that the US FDA has granted fast track designation to the combination of its ...